NCT04036617

Study of NaQuinate in Healthy Volunteers

A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of NaQuinate in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Haoma Medica Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Phase 1, randomised, double-blind, placebo-controlled study of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.

Detailed description

This first-in-human (FIH) clinical study is a Phase 1, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, and PK of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	NaQuinate	SAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150mg
DRUG	Placebo	SAD cohorts will receive 1 dose of placebo between 10-150 mg. MAD cohorts will receive 7 days dosing of placebo between 70-150mg

Timeline

• Start date: 2019-06-18
• Primary completion: 2019-12-31
• Completion: 2020-05-30
• First posted: 2019-07-30
• Last updated: 2019-07-30

Locations

1 site across 1 country: United Kingdom